Browse Drug Recalls

2,193 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,193 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 2,193 FDA drug recalls in NJ.

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DateProductReasonClassFirm
Jul 17, 2014 Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I... CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. Class II SST Corporation
Jul 14, 2014 buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, R... Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzo... Class III Wockhardt Usa Inc.
Jul 12, 2014 Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bot... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufa... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufa... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 m... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 3... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg,... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 12, 2014 Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufac... Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP gui... Class II Daiichi Sankyo Pharma Development
Jul 11, 2014 Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (... Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... Class III Sandoz Inc
Jul 2, 2014 E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manu... Subpotent Drug: Low out of specification results for both pH and assay obtained during routine st... Class III Bracco Diagnostic Inc
Jun 25, 2014 Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Ph... Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold co... Class I Pharmacy Creations
Jun 20, 2014 Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint F... Failed Impurity/Degradation Specification; 12-month stability time point Class III Novel Laboratories, Inc.
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count... Labeling: Incorrect or Missing Package Insert Class III Valeant Pharmaceuticals North America LLC
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 348 mg, a) 7-co... Labeling: Incorrect or Missing Package Insert Class III Valeant Pharmaceuticals North America LLC
Jun 5, 2014 APLENZIN¿ (bupropion hydrobromide), extended-release tablets, 522 mg, a) 7-co... Labeling: Incorrect or Missing Package Insert Class III Valeant Pharmaceuticals North America LLC
May 23, 2014 Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-cou... Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point. Class II Dr. Reddy's Laboratories, Inc.
May 22, 2014 Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufa... Presence of Foreign Substance: Presence of stainless steel particles. Class II Sandoz, Inc
May 21, 2014 Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmac... Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... Class III Valeant Pharmaceuticals North America LLC
May 21, 2014 Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-... Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of ... Class III Valeant Pharmaceuticals North America LLC
May 20, 2014 Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, ND... Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month ti... Class II West-Ward Pharmaceutical Corp.
May 16, 2014 Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsul... Subpotent Drug. Class II Actavis Inc
May 12, 2014 COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vi... Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic c... Class I Bristol-Meyers Squibb
May 8, 2014 PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. ... Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tabl... Class II Zydus Pharmaceuticals USA Inc
Apr 29, 2014 Vitamin C (ascorbic acid) Injection, USP, 500 mg per 2 mL, 50 x 2 mL ampoules... Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling... Class II Flawless Beauty LLC
Apr 29, 2014 Saluta (reduced glutathione) Powder for Injection, 600 mg/vial, packaged in 1... Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote. Class II Flawless Beauty LLC
Apr 29, 2014 Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes d... Class II Flawless Beauty LLC
Apr 29, 2014 Relumins Advanced Glutathione (lyophilized glutathione/vitamin C) injectable ... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates ... Class II Flawless Beauty LLC
Apr 29, 2014 Sterile Water for Injection, 5 mL ampoules, packaged in 50-count ampoules per... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates ... Class II Flawless Beauty LLC
Apr 29, 2014 Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials... Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes d... Class II Flawless Beauty LLC
Apr 28, 2014 TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bott... Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone ... Class II Ferring Pharmaceuticals Inc
Apr 17, 2014 Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-... Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long te... Class III Wockhardt Usa Inc.
Apr 10, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100-count bottle,... Failed Dissolution Specifications: Failure of dissolution test observed at three month time point. Class II Wockhardt Usa Inc.
Apr 1, 2014 Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, R... Failed Dissolution Specifications: failure of dissolution test observed at nine month time point. Class II Wockhardt Usa Inc.
Mar 18, 2014 Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: ... Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign mater... Class II Glenmark Generics Inc., USA
Mar 6, 2014 Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottl... Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and ide... Class I Greenstone Llc
Feb 10, 2014 Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured ... Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for... Class II Actavis Elizabeth LLC
Feb 7, 2014 Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephed... Defective Container: An unacceptable level of blister defects have been identified in Loratadine ... Class II Ohm Laboratories, Inc.
Feb 4, 2014 Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, ... Failed Dissolution Specifications: Product did not meet specification requirements for dissolution. Class II Actavis Elizabeth LLC
Jan 29, 2014 Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: ... Failed Tablet Specifications: Broken Tablets Present. Class II Caraco Pharmaceutical Laboratories Ltd.
Jan 16, 2014 Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Ma... Presence of Foreign Tablets: A product complaint was received by a pharmacist who discovered an A... Class II Ranbaxy Inc.
Jan 14, 2014 Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For M... Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that ... Class II Traxx International Corp
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister... Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which c... Class III Merck & Co Inc
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister... This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... Class III Merck & Co Inc
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister... This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... Class III Merck & Co Inc
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister... This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... Class III Merck & Co Inc
Jan 3, 2014 a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 1... Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count... Class II Dr. Reddy's Laboratories, Inc.
Dec 16, 2013 VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx On... Failed Stability Testing: This product is below specification for preservative content. Class III Bracco Diagnostics Inc
Dec 13, 2013 Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufac... Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP... Class II Corepharma LLC

Frequently Asked Questions

When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.